Tuesday, April 08, 2008

U.S. Supreme Court preemption decision: Riegel v. Medtronic, Inc.

You've probably already heard about the U.S. Supreme Court's decision in Riegel v. Medtronic, Inc., ___ U.S. ___ (Feb. 20, 2008), earlier this year. Last Thursday, The American Lawyer had an interesting article, "For Defendants Alone?" (subscription), about that and other preemption cases now before the Supreme Court: "All three cases turn on the court's developing view of federal preemption of state torts. Specifically, whether or not approval by the Food and Drug Administration immunizes the makers of pharmaceuticals and medical devices from state court damages claims."

A series of independent assessments have concluded that the agency is poorly organized, scientifically deficient and short of money. In February, its commissioner, Andrew C. von Eschenbach, acknowledged that the agency faces a crisis and may not be “adequate to regulate the food and drugs of the 21st century.”

The F.D.A. does not test experimental medicines but relies on drug makers to report the results of their own tests completely and honestly. Even when companies fail to follow agency rules, officials rarely seek to penalize them. “These are scientists, not cops,” said David Vladeck, a professor at Georgetown Law School.

Comments

Though FDA does require a 6 to 8 year submission and review period prior to issuing a PMA (pre market amendment) for a new drug or medical device, and to which the PMA process as opposed to the lesser regorous 510k filing, inevitably turned the USSC's decision on premption in Medtronic's favor (Riegel v Medtronic), the reality is that FDA relies to a significant degree on the mfr's HONEST submission of its clinical data and findings. With state premption for any culpability as to misrepresentations in PMAs now having been removed, mfr's will become more enboldened to mislead FDA. And with FDA having budget and resource limits, this raises the liklihood that knowingly unsafe drugs and devices will reach the market. It seems plausible that 17200 claims could be instead used in certain cases where mfr' "intentional deceit" rises to such a threshhold. As a scientist, I look to the legal experts to discern this.